Ignite Creation Date:
2024-05-06 @ 1:20 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03996200
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2019-06-21
Brief Title:
MINIject in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool
Sponsor:
iSTAR Medical
Organization:
iSTAR Medical
Study Overview
Official Title:
A Prospective Open Multicentre Clinical Trial Analysing the Efficacy and Safety of Miniject MINI SO627 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications Using a Single Operator Delivery Tool
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study to assess safety and performance of MINIject SO627 in patients with open angle glaucoma
Detailed Description:
The study will evaluate the efficacy and safety of MINI SO627 and IOP Intra- ocular pressure lowering effects with or without the use of glaucoma medications The procedure will be a stand alone surgery Patient follow up with several examinations up to 24 months after surgery
The primary endpoint is the reduction in medicated mean diurnal IOP at 6 months follow up compared to medicated diurnal IOP at baseline visit
The primary endpoint is the reduction in medicated mean diurnal IOP at 6 months follow up compared to medicated diurnal IOP at baseline visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None